The FDA recently published a statement regarding breast implants. Patients with either saline or silicone gel filled breast implants may have a very small risk for a rare cancer called anaplastic large-cell lymphoma (ALCL) adjacent to the implant.
Because the risk for ALCL is very small, the agency believes the weight of evidence “supports a reasonable assurance that FDA approved breast implants are safe and effective when used as labeled.”
A rare cancer of the immune system that can occur anywhere in the body, ALCL is diagnosed in 1 of every 500,000 women per year in the United States. ALCL in the breast is rarer still, diagnosed annually in roughly 3 of every 100 million women without implants. In women with implants, it is usually inside the fibrous scar tissue called a capsule surrounding the implant. It is not a cancer of the breast pr se.
Evidence suggests that the kind of ALCL found in conjunction with breast implants is less aggressive than the usual form of ALCL, and is sometimes treatble by simply removing the implant, the capsule and collected fluid.
In the last 25 years there are 34 cases of ALCL in women with breast implants throughout the world. The FDA is aware of 60 cases, however some of these maybe duplicates. An estimated 5 to 10 million women have received breast implants.
Of the 34 implants 24 were silicone and 7 were saline implants and 3 had no fill type recorded. 11 of the implants were for reconstruction, 19 for breast augmentation and no reason specified for the remaining 4. The median time for diagnosis was 8 years with a range between 1 and 23 years. Patients presented with implant related symptoms such as pain, swelling and lumps or asymmetry.
I was recently at a meeting and this topic was discussed. The American Society of Plastic Surgeons is putting together a registry to collect more information that will better characterize ALCL in women with breast implants. As you can see by the numbers this is exceedingly rare, so rare in fact that statistically it’s hard to say there is even a correlation between the two. I think it is important to be aware of this and if you notice a sudden increase in size of your breast, increased pain or a lump to immediately call your physician to be evaluated. If you have any questions or concerns regarding these symptoms I am happy to evaluate you. More information is available on the FDA website. The FDA’s prelimenary findings and analysis can be found here. For any questions please contact our Orlando plastic surgery practice in Winter Park Florida.